When I read the following article this morning, the first question I had was whether these Mylan employees overrode quality control guidelines for the Mylan fentanyl patch:

MORGANTOWN, W.Va. — Late this spring, Mylan Inc. took the unusual step of halting production at its sprawling generic drug manufacturing plant in Morgantown for an emergency meeting. Hundreds of employees, gathered in the cafeteria, were about to hear a bombshell.

Days earlier, Mylan learned two production workers had violated government-mandated quality control procedures intended to ensure the safety and effectiveness of prescription drugs. The company was launching a probe.

Publicly, Mylan officials have refused to discuss or even acknowledge the matter.

But according to a confidential internal report obtained by the Pittsburgh Post-Gazette, the company discovered that workers were routinely overriding computer-generated warnings about potential problems with the medications they were producing.

Source: http://www.post-gazette.com/pg/09207/986516-28.stm#ixzz0MT8ZvQJB

The article doesn't specifically mention the Mylan fentanyl patch, but it doesn't exclude it, either.  I'm glad that Mylan management took the initiative to launch an investigation, but I'm disturbed that overriding the quality control mechanisms was apparently as simple as "right-clicking" the red screen.

Many people refer to Windows crashes as "The Blue Screen of Death." If Mylan employees knowingly released defective fentanyl patches, perhaps we should start talking about "The Red Screen of Death," as a defective patch can certainly kill someone.  In fact, many lawsuits have been filed over deaths attributed to Mylan fentanyl patches already.

This one is a mouth patch, and it isn’t supposed to be used as a substitute for the Duragesic patch or the other generic fentanyl patches.

The U.S. Food and Drug Administration on Thursday formally approved Onsolis, Raleigh-based BDSI's mouth patch that delivers the painkilling drug fentanyl to cancer patients suffering severe “breakthrough pain” that doesn't respond to other medications.

Onsolis is manufactured by Aveva Drug Delivery Systems of Florida and marketed under license from BDSI (Nasdaq: BDSI) by Meda Pharmaceuticals. With FDA approval of Onsolis, BDSI is due about $27 million in milestone payments, which Sirgo said would be directed to the company's drug pipeline.

The company also is developing the product BEMA Buprenorphine, a form of painkilling drug buprenorphine that is often given intravenously to treat chronic pain. Like Onsolis, the product uses the company's BEMA technology, which delivers drugs through mucous membranes in the mouth via a small patch.

Onsolis was approved with a boxed warning, which states that the medication should not be used for the management of migraines, dental pain, or postoperative pain or by patients who use opioids intermittently. It also warns that the drug should be kept out of the reach of children and should not be substituted for other fentanyl products.

Source: FDA approval pumps $27M into BDSI pipeline – Triangle Business Journal:

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Johnson & Johnson, the makers of the Duragesic fentanyl patch reported that sales for the patch are down 12.3% worldwide from this quarter last year.

Duragesic Sales Down

One has to wonder if all of the Duragesic recalls and bad press over the various lawsuits has eaten into sales.  Note that U.S. sales are down much more than global.

Here’s a link to the PDF reporting J&J’s earnings.

I wish them the best of luck.  I also wish that they’ll send me any documents they obtain from the Canadian subsidiaries they plan on suing.

EDMONTON — The last time Ellen Robb spoke with her brother, he was doing chores and laundry at home, optimistic that with his chronic back pain under control, he would soon be back at work as an electrician.

Four days later, after many unanswered phone calls, Robb found Doug Hoy dead on his apartment floor, barefoot as if he were on his way to get his laundry basket across the hall.

Months later, a toxicology report revealed Hoy’s blood had three times the safe amount of fentanyl, Robb said.

Fentanyl is an opiate 80 to 100 times as strong as morphine, and approved for use as a pain medication in Canada and the United States.

Hoy had been prescribed the fentanyl patch to treat his severe chronic back pain after another powerful opiate, OxyContin, failed to bring relief.

Now, Robb and her family have taken steps to launch a class-action lawsuit against five pharmaceutical companies, alleging the companies that design, test and distribute fentanyl patches were negligent in warning people about the risks of breathing problems or death, as well as severe weakness, drowsiness and confusion.

Source: Family of dead Alta. man seeks class-action lawsuit against drug-makers

 As I keep adding to the stockpile of documents produced in generic fentanyl patch lawsuits and Duragesic lawsuits, I’ll post a monthly update as to what’s available.  Here’s what I have posted so far:

I may have a few more documents pertaining to fentanyl or Duragesic side effects, but that ought to keep you busy reading for a loooong time.

 The two most popular types of Fentanyl patches are the reservoir design, and the matrix design.  Immediately below is a diagram of the reservoir design:

Duragesic Fentanyl Patch

As you can see, the reservoir patch gets its name from the fact that the fentanyl is contained in a reservoir.  In Duragesic fentanyl patches and authorized generics such as the Sandoz fentanyl patch, this reservoir will be filled with a fentanyl gel.  And now, the matrix patch:

matrix fentanyl patch

There is no fentanyl gel in a matrix style patch.  Mylan pharmaceuticals makes a matrix patch.  A matrix fentanyl patch places the fentanyl in adhesive.  There is therefore no gel to link.  The matrix design is inherently safer because it cannot leak gel.

Duragesic Fentanyl Patch

The following expert report from Swicegood v. Pliva, Inc. explains how Metoclopramide (generic Reglan) can cause movement disorders, such as Tardive Dystonia and Tardive Dyskinesia.

I noticed that Robert Gale is mentioned here as well.  He’s the inventor of the Duragesic fentanyl patch; I’m not yet sure what involvement he has with Reglan / Metaclopramide.

Continue Reading Expert Report in Metoclopramide Lawsuit

What’s of particular interest to me is the fact that Robert Gale was deposed about the problems inherent with the Duragesic patch way back in 1996.  Now that’s a deposition I’m going to try and get a hold of.

Way back in the 90’s, there hadn’t been as many problems or as much publicity about the Duragesic patch.  You never know what Gale might have said under those circumstances.

Continue Reading Testimony from a Duragesic patch lawsuit from 1996

Interesting information regarding the development of ALZA and Mylan’s patches.

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MARIO A. GONZALEZ having first been duly sworn, was examined and testified as follows:

COURTROOM deputy: Please take the stand, Dr.

THE COURT: Good afternoon, Dr.

THE WITNESS: Good afternoon, Your Honor.

MS. DAVIS: should I proceed, Your Honor?

THE COURT: Yes

DIRECT EXAMINATION BY MS. DAVIS:

Q. Good afternoon, Dr. Gonzalez.

A. Good afternoon.

Q. Would you please tell the court where you reside?

A. I live in Pembroke Pines, Florida.

Q. what is your present employment, Dr. Gonzalez?

A. Well as of a few weeks ago, I was President of Global Max Americas. ICON clinical is a large CRO. They announced that they are purchasing us, that they have purchased us. And I will – and that was my old job.

I will continue consulting as a pharmacoki neti ci st.

Q. Could you just explain what a CRO – you used that term – I'm not sure we are all familiar with that acronym.

A. CRO is abbreviation for a Contract Research organization. Global Max Americas was part of the Global Max Group which was a group of about 80 scientists doing consulting work and running clinical studies and helping companies develop products. And ICON is about 3,000, scientists so they are bigger than us. They made an offer we couldn't refuse. And we are being bought.

Q. Would you describe briefly to us your areas of expertise or the areas in which you perform consulting?

A. I'm a pharmacokineticist. I consult primarily in pharmacokinetics and other issues related to clinical pharmacology. Meaning pharmacology applied to humans and the effect of drugs in humans.

My work in pharmacokinetics has primarily focused on control release delivery systems, both oral and transdermal. So most of the consulting I do usually involves the drug that is not an immediate release product.

Q. So an immediate release would be something that goes in once and immediately gets dispersed through the body, as opposed to controlled release where the drug comes out over time?

A. That's right. A controlled release product is, as the name implies, the drug is being physical, chemically controlled by the dosage form. A transdermal system is a perfect example of that.

Q. And you mentioned pharmacokinetics. Could you define for us or describe for us what aspects of the study of drugs and how they operate is covered under the definition of pharmacokinetics?

A. Yeah. There is the little – a little acronym 1 we always talk about pharmacokinetics, ADMS. And it stands for absorption, distribution, metabolism and excretion. So pharmacokinetics is really the study of how drugs move around in the body, sort of a cocktail party description of the term.

And what we do is we basically use mathematics to describe the absorption, or how the drug distributes, or how it gets eliminated. Elimination is a combination of both metabolisms and excretion. Excretion meaning that the drug comes out of the body without being metabolized. For example, Fentanyl – 10 percent of a Fentanyl dose comes out unchanged in the urine. That's excretion.

Q. And what happens to the other 90 percent?

Continue Reading Testimony of Mario Gonzalez in ALZA v. Mylan Fentanyl Patent Lawsuit